8-K – Current report

August 14, 2015 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, reported financial results for the three and six months ended June 30, 2015 (Filing, 8-K, EntreMed, AUG 14, 2015, View Source [SID:1234507259]).

CASI reported a net loss for the second quarter of 2015 of ($2.1 million), or ($0.06) per share. This compares with a net loss of ($1.6 million), or ($0.06) per share, for the same period last year. For the first six months of 2015 the net loss was ($3.9 million), or ($0.12) per share, compared with a net loss of ($3.1 million), or ($0.11) per share, for the first six months of 2014.

As of June 30, 2015, CASI had cash and cash equivalents of approximately $8.0 million.

Sara B. Capitelli, CASI’s Vice President, Finance, commented on the second quarter results, "Our second quarter 2015 financial results were in line with expectations. Research and development expenses increased compared with the previous year primarily due to higher clinical trial costs associated with our food effect study of ENMD-2076 in healthy human subjects, an increase in patient enrollment on other clinical trials, as well as increased costs associated with our research and development operations in China during 2015. General and administrative expenses for the second quarter of 2015 decreased compared with the previous year, reflecting lower non-cash stock-based compensation expense, partially offset by an increase in foreign patent related costs. As we continue to execute our clinical development plan, we expect operating expenses to accordingly increase in 2015."

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "We continue to make progress with our pipeline, including moving forward with our plans to initiate a Phase 2 clinical trial in the U.S. for ENMD-2076 in patients with Fibrolamellar Carcinoma (FLC), and to complete our import drug regulatory submissions for ZEVALIN and MARQIBO in China and Taiwan, as well as to finalize our distribution and supply arrangements in those territories. As reported earlier, ZEVALIN is now available to patients in Hong Kong. We remain deeply committed to aggressively pursuing our clinical development milestones, commercialization of products and business development opportunities."

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Genmab Enters Commercial License Agreement with Novo Nordisk for DuoBody Technology

On August 14, 2015 Genmab A/S (OMX: GEN) reported it has entered an agreement to grant Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs (Press release, Genmab, AUG 14, 2015, View Source [SID:1234507251]). The bispecific antibodies will target a disease area outside of cancer therapeutics. Under the terms of the agreement, Genmab will receive an upfront payment of USD 2 million from Novo Nordisk.

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After an initial period of exclusivity for the two target combinations, Novo Nordisk has an option to maintain exclusivity or take the licenses forward on a non-exclusive basis. Genmab is entitled to potential development, regulatory and sales milestones of up to approximately USD 250 million for each exclusive license, or approximately USD 200 million for each non-exclusive license. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products.

"Our proprietary DuoBody technology can be used to create bispecific antibodies that target a wide variety of disease areas. Today’s agreement with Novo Nordisk is an example of how we can leverage access to our unique state-of-the art antibody expertise and collaborations to generate diverse revenue streams in areas beyond cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab."

This agreement is not expected to have a material impact on Genmab’s 2015 financial guidance.

About the DuoBody Platform
The DuoBody platform is Genmab’s proprietary technology platform for the discovery and development of bispecific antibodies. Bispecific antibodies bind to two different epitopes (or "docking" sites) either on the same, or on different targets (also known as dual-targeting). Dual-targeting may improve binding specificity and efficacy in inactivating disease targets. Bispecific antibodies generated with the DuoBody platform may improve antibody therapy of cancer, autoimmune, and infectious and central nervous system disease. DuoBody molecules are unique in combining the benefits of bispecificity with the strengths of conventional antibodies, which allows DuoBody molecules to be administered and dosed the way other antibody therapeutics are. Genmab’s DuoBody platform generates bispecific antibodies via a fast and broadly applicable process, which is easily performed at standard bench, as well as commercial manufacturing scale.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Sophiris Bio, AUG 13, 2015, View Source [SID:1234507257])

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10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, OncoGenex Pharmaceuticals, AUG 13, 2015, View Source [SID:1234507255])

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10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, GlobeImmune, AUG 13, 2015, View Source [SID:1234507252])

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